Brufen 400mg film-coated Tablets
*Company:
Mylan IRE Healthcare LtdStatus:
No Recent UpdateLegal Category:
Product subject to medical prescription which may be renewed (B)Active Ingredient(s):
*Additional information is available within the SPC or upon request to the company
Updated on 22 January 2024
File name
ie-pl-brufen-400mg-pr3327535-PRAC-clean.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 4 - possible side effects
- Change to section 4 - how to report a side effect
Updated on 22 January 2024
File name
ie-spc-brufen-400mg-pr3327535-PRAC-clean.pdf
Reasons for updating
- Change to section 4.8 - Undesirable effects
- Change to Section 4.8 – Undesirable effects - how to report a side effect
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 22 January 2024
File name
ie-spc-brufen-400mg-pr3327535-PRAC-clean.pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 28 November 2023
File name
ie-pl-brufen-400mg-pr3083488-maht-clean.pdf
Reasons for updating
- Change to section 6 - marketing authorisation holder
Updated on 28 November 2023
File name
ie-pl-brufen-400mg-pr3083488-maht-clean.pdf
Reasons for updating
- Change to section 6 - marketing authorisation holder
Updated on 28 November 2023
File name
ie-pl-brufen-400mg-pr3083488-maht-clean.pdf
Reasons for updating
- Change to section 6 - marketing authorisation holder
Updated on 28 November 2023
File name
ie-pl-brufen-400mg-pr3083488-maht-clean.pdf
Reasons for updating
- Change to section 6 - marketing authorisation holder
Updated on 28 November 2023
File name
ie-spc-brufen-400mg-pr3083488-maht-clean.pdf
Reasons for updating
- Change to section 7 - Marketing authorisation holder
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 29 November 2022
File name
ie-pl-brufen-400mg-TIB-PRAC-Codein use during Pregnancy-clean-SEP2022.pdf
Reasons for updating
- Change to section 2 - pregnancy, breast feeding and fertility
- Change to section 6 - date of revision
Updated on 29 November 2022
File name
ie-spc-brufen-400mg-TIB-PRAC-Codein use during pregnancy-clean-SEP2022.pdf
Reasons for updating
- Change to section 4.6 - Pregnancy and lactation
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 03 November 2020
File name
ie-pl-brufen-400mg-TIB-PRAC-excipients-clean.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 3 - how to take/use
- Change to section 6 - date of revision
Updated on 03 November 2020
File name
ie-spc-brufen-400mg-TIB-PRAC-excipients-clean.pdf
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 4.2 - Posology and method of administration
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 09 January 2020
File name
ie-SmPC-Brufen400mg-07Jan2019-CRN009GSD-TIAIN-clean.pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.8 - Undesirable effects
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 09 January 2020
File name
ie-PIL_Brufen400mg-07Jan2019-CRN009GSD-TIAIN-eMC.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Updated on 14 June 2019
File name
ie-SmPC-Brufen400-10Apr2018-CRN2204117-clean.pdf
Reasons for updating
- Change to improve clarity and readability
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 17 January 2019
File name
ie-PIL-Brufen400mg-TIAin_07-Dec-2018-Clean_EMC.pdf
Reasons for updating
- Change to section 6 - date of revision
Updated on 03 January 2019
File name
ie-PIL-Brufen400mg-TIAin_07-Dec-2018-Clean_EMC.pdf
Reasons for updating
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
Updated on 13 May 2018
File name
ie-SmPC-Brufen400-10Apr2018-CRN2204117-clean.docx
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 10 May 2018
File name
ie-SmPC-Brufen400-10Apr2018-CRN2204117-clean.docx
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 4.1 - Therapeutic indications
- Change to section 4.2 - Posology and method of administration
- Change to section 4.3 - Contraindications
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to section 4.6 - Pregnancy and lactation
- Change to section 4.7 - Effects on ability to drive and use machines
- Change to section 4.8 - Undesirable effects
- Change to section 4.9 - Overdose
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 26 April 2018
File name
ie-PIL-Brufen400mg-10Apr2018-CRN2204117-emc.pdf
Reasons for updating
- Change to section 1 - what the product is used for
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 3 - how to take/use
- Change to section 4 - possible side effects
Updated on 06 June 2017
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 06 June 2017
Reasons for updating
- Change to section 7 - Marketing authorisation holder
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
7. MARKETING AUTHORISATION HOLDER
Mylan IRE Healthcare Limited
Unit 35/36
Grange Parade
Baldoyle Industrial Estate
Dublin 13
BGP Products Ireland Limited
4051 Kingswood Drive
Citywest Business Campus
Dublin 24
10. DATE OF REVISION OF THE TEXT
February 2017June 2017
Updated on 02 June 2017
File name
PIL_12783_498.pdf
Reasons for updating
- New PIL for new product
Updated on 02 June 2017
Reasons for updating
- Change to section 6 - marketing authorisation holder
- Change to section 6 - date of revision
Updated on 13 December 2016
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 4.2 - Posology and method of administration
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.8 - Undesirable effects
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Changes to SmPC affecting sections
4.2 Posology and Method of administration – to include age/weight qualifiers and information related to use of product with renal and hepatic impairment
Section 4.4 Special warnings and precautions for use.
· Warnings added with respect to use low dose especially in long term use.
· Use may cause headaches do not take additional painkillers
· Concomitant consumption of alcohol may increase adverse events (particularly those that are GI)
· Addition of elderly when discussing risk of dehydrated patients
· Warnings related to varicella have been added.
Section 4.7 Effects on ability to drive and use machines – advised risks enhanced if tablets and alcohol combined.
Section 4.8 undesirable effects – some changes to the frequency of adverse events.
Updated on 09 December 2016
Reasons for updating
- Change to Section 1 - what the product is
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 2 - interactions with other medicines, food or drink
- Change to section 3 - dose and frequency
- Change to section 3 - how to take/use
- Change to section 4 - possible side effects
- Change to section 6 - what the product contains
- Change to section 6 - what the product looks like and pack contents
Updated on 22 September 2016
Reasons for updating
- Change to date of revision
Updated on 22 April 2016
Reasons for updating
- Change of manufacturer
Updated on 08 January 2016
Reasons for updating
- Change to section 4.3 - Contraindications
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to section 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Section 4.4 - (Special Warnings and Precautions for Use) in section Cardiovascular and cerebrovascular effects warnings updated based on clinical studies and warning of use of high doses.
Section 4.5 - (Interaction with Other medicinal products and other forms of interaction - table amended possible effects concomitant use with Acetylsalicylic acid/aspirin.
Section 4.8 - (Undesirable effects) - warnings changed in section "Cardiac disorders and vascular disorders"
Section 5.1 - (Pharmacodynamic properties) information changed relating from data/studies related to use with acetylsalicylic acid and possible reduction of cardioprotective effect of low dose aspirin.
Updated on 05 January 2016
Reasons for updating
- Change to warnings or special precautions for use
Updated on 21 September 2015
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 4.3 - Contraindications
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to section 4.6 - Pregnancy and lactation
- Change to section 4.8 - Undesirable effects
- Change to Section 4.8 – Undesirable effects - how to report a side effect
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 5.2 - Pharmacokinetic properties
- Change to section 5.3 - Preclinical safety data
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Updates to paragraph headers & addition of a paragraph relating to Method of Administration.
Section 4.3:
Update to the list of contraindications
Editorial changes
Section 4.4:
Editorial changes
Addition of excipient warning
Addition of respiratory disorder caution
Section 4.5:
Addition of new interaction table
Section 4.6:
Editorial changes
Section 4.8:
Addition of paragraphs relating to Infections and infestations and Skin and subcutaneous tissue disorder,
Addition of a new MedDRA table
Addition of Adverse Event reporting details
Section 5.1:
Addition of pharmacotherapeutic classification
Editorial changes
Addition of paragraphs relating to Absorbtion, Distribution, Biotransformation, Elimination.
Addition of paragraphs relating to Special populations (Elderly, Paediatric population, Renal Impairment and Hepatic Impairment)
Section 5.3:
Editorial changes
Section 10:
Update to revision date
Updated on 18 September 2015
Reasons for updating
- Change to warnings or special precautions for use
- Change of contraindications
- Change to drug interactions
- Change to dosage and administration
- Addition of information on reporting a side effect.
Updated on 14 April 2015
Reasons for updating
- Change to section 7 - Marketing authorisation holder
- Change to section 8 - MA number
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
MA Holder changed from Abbott Laboratories Ireland Limited to BGP Products Ireland Limited
Section 8:
PA number changed from PA 38/80/02 to PA 2010/2/1
Updated on 09 April 2015
Reasons for updating
- Change to marketing authorisation holder
Updated on 20 June 2014
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Addition of "There is a risk of renal impairment in dehydrated children and adolescents"
Updated on 18 June 2014
Reasons for updating
- Change to warnings or special precautions for use
Updated on 25 July 2013
Reasons for updating
- Improved electronic presentation
Updated on 23 April 2013
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 4.3 - Contraindications
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to section 4.6 - Pregnancy and lactation
- Change to section 4.7 - Effects on ability to drive and use machines
- Change to section 4.8 - Undesirable effects
- Change to section 4.9 - Overdose
- Change to section 5.1 - Pharmacodynamic properties
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Updated on 18 April 2013
Reasons for updating
- Change to warnings or special precautions for use
- Change of contraindications
- Change to side-effects
- Change to drug interactions
- Change to information about pregnancy or lactation
- Change to information about driving or using machinery
- Change to date of revision
Updated on 16 April 2013
Reasons for updating
- Change to name of manufacturer
Updated on 21 January 2013
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Addition of the following information: Section 4.2:
Take Brufen tablets with a glass of water. Brufen tablets should be swallowed whole and not chewed, broken, crushed or sucked on to avoid oral discomfort and throat irritation.
Date of revision of text updated to Dec 12
Updated on 18 January 2013
Reasons for updating
- Change to date of revision
- Change to dosage and administration
Updated on 08 August 2011
Reasons for updating
- Improved electronic presentation
Updated on 20 April 2011
Reasons for updating
- Change due to user-testing of patient information
Updated on 26 January 2011
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 3 - Pharmaceutical form
- Change to section 4.3 - Contraindications
- Change to section 6.1 - List of excipients
- Change to section 6.4 - Special precautions for storage
- Change to section 6.5 - Nature and contents of container
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Section 2: the excipient soya lecithin has been removed.
Section 3: "----with 'Brufen 400' printed in black on one face" has been removed.
Section 4.3: Contraindication regarding allergy to soya & peanut has been removed.
Section 6.1: Opacode S-1-8152HV black (contains shellac, soya lecithin, iron oxide black and antifoam DC1510. has been removed from the list of excipients.
Section 6.4: "Keep the container tightly closed in order to protect from moisture" has been chnaged to "Store in the original package in order to protect from moisture".
Section 6.5: HDPE bottles have been removed and replaced with "Blister pack comprising of transparent polyvinyl chloride (PVC) or polyvinyl chloride/polyvinylidene (PVC/PVDC) film with aluminium foil backing". Pack size has changed to 60 tablets.
Section10. Date of revision has been revised to 19 January 2011.
Updated on 02 November 2010
Reasons for updating
- Change to section 6.1 - List of excipients
- Change to section 6.4 - Special precautions for storage
- Change to section 1 - Name of medicinal product
- Change to section 2 - Qualitative and quantitative composition
- Change to section 4.3 - Contraindications
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Section 2: Qualitative & Quantitative composition of lactose monohydrate and soya lecithin added.
Section 4.3. The following statement has been added:
Brufen 400mg film-coated tablets contains soya lecithin. If you are allergic to soya or peanut, do not use this medicinal product.
Section 6.1: Composition of Opadry white listed, Dimeticine chnaged to antifoam.
Section 6.4: "Store in original container removed" and replaced with "Keep the container tightly closed in order to protect from moisture".
Updated on 01 November 2010
Reasons for updating
- Change of inactive ingredient
- Change to warnings or special precautions for use
- Change to storage instructions
Updated on 10 February 2010
Reasons for updating
- Change to warnings or special precautions for use
- Change to side-effects
- Change to drug interactions
Updated on 08 February 2010
Reasons for updating
- Change to section 4.3 - Contraindications
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to section 4.6 - Pregnancy and lactation
- Change to section 4.8 - Undesirable effects
- Change to section 4.9 - Overdose
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
4.3 Contraindications
Brufen is contraindicated in patients with known hypersensitivity to the active substance or to any of the inactive ingredients.
Brufen is contraindicated in patients with a history of gastrointestinal bleeding or perforation, related to previous NSAIDs therapy. Active, or history of recurrent peptic ulcer/haemorrhage (two or more distinct episodes of proven ulceration or bleeding).
Brufen is contraindicated in patients with severe heart failure.
Brufen should not be used in patients with known hypersensitivity or who have experienced asthma, urticaria or allergic-type reactions after taking Brufen, aspirin or other NSAIDs.
4.5 Interactions with Other Medicaments and Other Forms of Interaction
It is considered unsafe to take NSAIDs in combination with warfarin or heparin unless under direct medical supervision.
Care should be taken in patients treated with any of the following drugs as interactions have been reported:
Antihypertensives: NSAIDs may reduce the effect of anti-hypertensives, such as ACE inhibitors..
Diuretics: NSAIDs may reduce the diuretic effect. Diuretics can also increase the risk of nephrotoxicity of NSAIDs.
Cardiac glycosides: NSAIDs may exacerbate cardiac failure, reduce GFR and increase plasma cardiac glycoside levels.
Lithium: NSAIDs may decrease elimination of lithium.
Methotrexate: NSAIDs may decrease elimination of methotrexate.
Cyclosporin: increased risk of nephrotoxicity with NSAIDs.
Other analgesics including cyclooxygenase-2 selective inhibitors: avoid concomitant use of two or more NSAIDs, (including aspirin) as this may increase the risk of adverse effects (see section 4.4).
Corticosteroids: increased risk of gastrointestinal ulceration or bleeding with NSAIDs (See section 4.4)
Anticoagulants: NSAIDs may enhance the effects of anticoagulants, such as warfarin (See section 4.4).
Aspirin: As with other products containing NSAIDs, concomitant administration of ibuprofen and aspirin is not generally recommended because of the potential of increased adverse effects.
Experimental data suggest that ibuprofen may inhibit the effect of low dose aspirin on platelet aggregation when they are dosed concomitantly. However, the limitations of these data and the uncertainties regarding extrapolation of ex vivo data to the clinical situation imply that no firm conclusions can be made for regular ibuprofen use, and no clinically relevant effect is considered to be likely for occasional use (see section 5.1).
Anti-platelet agents and selective serotonin reuptake inhibitors (SSRIs): increased risk of gastrointestinal bleeding with NSAIDs (See section 4.4).
Aminoglycosides: NSAIDs may decrease the excretion of aminoglycosides.
Quinolone antibiotics: animal data indicate that NSAIDs can increase the risk of convulsions associated with quinolone antibiotics. Patients taking NSAIDs and quinolones may have increased risk of developing convulsions.
Probenacid: there have been no reports of interactions between probenacid and ibuprofen. However, probenacid produces a reduction in metabolism and elimination of some NSAIDs and metabolites.
Oral hypoglycaemic agents: inhibition of metabolism of sulfonylurea drugs, prolonged half-life and increased risk of hypoglycaemia.
Mifepristone: NSAIDs should not be used for 8-12 days after mifepristone administration as NSAIDs can reduce the effect of mifepristone.
Tacrolimus: Possible increased risk of nephrotoxicity when NSAIDs are given with tacrolimus.
Zidovudine: Increased risk of haematological toxicity when NSAIDs are given with zidovudine. There is evidence of an increased risk of haemarthroses and haematoma in HIV(+) haemophiliacs receiving concurrent treatment with zidovudine and ibuprofen.
Ginkgo biloba may potentiate the risk of bleeding with NSAIDs.
4.6 Pregnancy and Lactation
Whilst no teratogenic effects have been demonstrated in animal toxicology studies, the use of ibuprofen during pregnancy should be avoided except under compelling circumstances. Congenital abnormalities have been reported in association with ibuprofen administration in man; however, these are low in frequency and do not appear to follow any discernible pattern. In view of the known effects of NSAIDs on the foetal cardiovascular system (closure of ductus arteriosus), ibuprofen should not be used in the third trimester of pregnancy.
Labour and delivery: Administration of ibuprofen is not recommended during labour and delivery. The onset of labour may be delayed and the duration increased with a greater bleeding tendency in both mother and child.
In limited studies to date, ibuprofen appears in breast milk in very low concentrations. Brufen is not recommended for use in nursing mothers.
4.8 Undesirable Effects
Immune system disorders:
Hypersensitivity reactions have been reported following treatment with ibuprofen. These may consist of (a) non-specific allergic reaction and anaphylaxis, (b) respiratory tract reactivity comprising asthma, aggravated asthma, bronchospasm or dyspnoea, or (c) assorted skin disorders, including rashes of various types, pruritus, urticaria, purpura, angioedema and, very rarely , bullous dermatoses (including Stevens-Johnson syndrome, toxic epidermal necrolysis and erythema multiforme).
Gastrointestinal disorders:
The most commonly observed adverse events are gastrointestinal in nature. Peptic ulcers, perforation or GI bleeding, sometimes fatal, particularly in the elderly, may occur (See section 4.4). Nausea, vomiting, diarrhoea, flatulence, constipation, dyspepsia, abdominal pain, melaena, haematemesis, ulcerative stomatitis, exacerbation of colitis and Crohn’s disease (See section 4.4 - Special warnings and precautions for use) have been reported following administration. Less frequently, gastritis has been observed. Pancreatitis has been reported very rarely.
Other adverse events reported include:
Cardiovascular: Oedema, hypertension and cardiac failure have has been reported in association with NSAID treatment. Clinical trial and epidemiological data suggest that use of ibuprofen, particularly at high dose (2400 mg/ daily), and in long term treatment may be associated with a small increased risk of arterial thrombotic events (for example myocardial infarction or stroke) (see section 4.4).
Blood and lymphatic system disorders: thrombocytopenia, neutropenia, agranulocytosis, aplastic anaemia and haemolytic anaemia.
Psychiatric disorders: depression, confusion, hallucinations
Nervous system disorders: headaches, paraesthesia, dizziness, drowsiness
Eye disorders: disturbances of vision, optic neuritis
Ear and labyrinth disorders: vertigo, tinnitus
Hepatobiliary disorders: abnormal liver function, hepatic failure, hepatitis, jaundice
Skin and subcutaneous tissue disorders: photosensitivity, bullous reactions including Steven's Johnson syndrome and toxic epidermal necrolysis (very rare).
General disorders and administration site conditions: malaise, fatigue.
Renal and urinary disorders: impaired renal function, renal nephrotoxicity in various forms, including interstitial nephritis, nephrotic syndrome and renal failure.
4.9 Overdose
Symptoms include nausea, vomiting, dizziness, convulsion, loss of consciousness and depression of the CNS and respiratory system. Large overdoses are generally well tolerated when no other drugs are involved.
Treatment consists of gastric lavage and, if necessary, correction of serum electrolytes and appropriate supportive measures.
There is no specific antidote to ibuprofen.
Updated on 13 January 2009
Reasons for updating
- Change to drug interactions
Updated on 12 January 2009
Reasons for updating
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to section 5.1 - Pharmacodynamic properties
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Change to section 5.1 - Pharmacodynamic Properties
Updated on 27 August 2008
Reasons for updating
- Change to section 9 - Date of renewal of authorisation
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Updated on 23 January 2008
Reasons for updating
- New PIL for new product
Updated on 21 June 2007
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 4.3 - Contraindications
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to section 4.8 - Undesirable effects
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Change to section 4.2 - Posology and Method of Administration
Change to section 4.3 - Contra-indications
Change to section 4.4 - Special warnings and Precautions
Change to section 4.5 - Interactions with other Medicaments and other forms of Interaction
Change to section 4.8 - Undesirable Effects
Updated on 11 July 2006
Reasons for updating
- Change to section 6.1 - List of excipients
- Change to section 9 - Date of renewal of authorisation
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Updated on 23 November 2004
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 09 August 2004
Reasons for updating
- Change to section 3 - Pharmaceutical form
- Change to section 6.1 - List of excipients
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 24 June 2003
Reasons for updating
- New SPC for medicines.ie
Legal category:Product subject to medical prescription which may be renewed (B)